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Simvastatin Side Effects

Report Simvastatin Side Effects

If you experienced any harmful or unwanted effects of Simvastatin, please share your experience. This could help to raise awareness about Simvastatin side effects, identify uknown risks and inform health professionals and patients taking Simvastatin.

Examples: headache, dizziness


The most commonly reported Simvastatin side effects are:
Muscle Pain (93 reports)
Leg Muscles/ Severe Pain (63 reports)
Back Muscles (51 reports)
Soreness Of Neck (40 reports)
Memory Impairment (35 reports)
Abdominal Pain (28 reports)
Muscle Pain, Soreness Of Neck And Back Muscles (25 reports)
Pain (15 reports)
Back Ache (14 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Simvastatin side effects . You can also compare Simvastatin side effects or view FDA reports.

Simvastatin Side Effects reported to FDA

The following Simvastatin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
The FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Simvastatin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.

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Abdominal Distension
on Mar 06, 2014 Male from GB , 67 years of age, weighting 207.0 lb, was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: abdominal distension. Simvastatin dosage: N/A.
Associated medications used:

Pain In Extremity, Erectile Dysfunction, Insomnia, Mood Swings
Patient was taking Simvastatin. Patient felt the following Simvastatin side effects: pain in extremity, erectile dysfunction, insomnia, mood swings on Mar 06, 2014 from GB Additional patient health information: Male , 58 years of age, weighting 224.0 lb, was diagnosed with and. Simvastatin dosage: Unk.

Abdominal Distension
Adverse event was reported on Mar 06, 2014 by a Male taking Simvastatin (Dosage: Unk) . Location: GB , 67 years of age, weighting 207.0 lb, After Simvastatin was administered, patient encountered several Simvastatin side effects: abdominal distension.
Multiple concurrent drugs taken:

Weight Decreased, Hepatitis, Myalgia, Lethargy, Asthenia
on Mar 05, 2014 Male from GB , 82 years of age, weighting 163.1 lb, was diagnosed with and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: weight decreased, hepatitis, myalgia, lethargy, asthenia. Simvastatin dosage: N/A.
Associated medications used:


Megacolon, Volvulus
on Mar 04, 2014 Male from GB , 70 years of age, was treated with Simvastatin. Patient felt the following Simvastatin side effects: megacolon, volvulus. Simvastatin dosage: 40mg.
Multiple prescriptions taken: Patient was hospitalized.

Abdominal Distension
Patient was taking Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: abdominal distension on Mar 04, 2014 from GB Additional patient health information: Male , 67 years of age, weighting 207.0 lb, . Simvastatin dosage: N/A.
Multiple concurrent drugs taken:

Headache, Constipation, Dyspepsia, Dizziness, Myalgia, Nasopharyngitis
Adverse event was reported on Mar 04, 2014 by a Male taking Simvastatin (Dosage: N/A) was diagnosed with and. Location: GB , 75 years of age, weighting 224.0 lb, Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: headache, constipation, dyspepsia, dizziness, myalgia, nasopharyngitis.
Associated medications used: Patient was hospitalized.

Myalgia, Muscular Weakness, Fatigue, Muscle Atrophy, Blood Creatine Phosphokinase Increased, Myositis, Exercise Tolerance Decreased
on Mar 03, 2014 Male from GB , 51 years of age, weighting 152.1 lb, was diagnosed with and was treated with Simvastatin. Patient felt the following Simvastatin side effects: myalgia, muscular weakness, fatigue, muscle atrophy, blood creatine phosphokinase increased, myositis, exercise tolerance decreased. Simvastatin dosage: N/A.

Dizziness, Panic Reaction, Road Traffic Accident, Blood Count Abnormal
on Mar 03, 2014 Patient from DE , 67 years of age, was diagnosed with and was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: dizziness, panic reaction, road traffic accident, blood count abnormal. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:

Myalgia, Muscular Weakness, Fatigue, Muscle Atrophy, Blood Creatine Phosphokinase Increased, Myositis, Exercise Tolerance Decreased
Patient was taking Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: myalgia, muscular weakness, fatigue, muscle atrophy, blood creatine phosphokinase increased, myositis, exercise tolerance decreased on Mar 03, 2014 from GB Additional patient health information: Male , 51 years of age, weighting 152.1 lb, was diagnosed with and. Simvastatin dosage: Unk.

Mood Swings, Pain In Extremity, Erectile Dysfunction, Insomnia
Adverse event was reported on Mar 01, 2014 by a Male taking Simvastatin (Dosage: 40 Mg) was diagnosed with and. Location: GB , 58 years of age, weighting 224.0 lb, Patient felt the following Simvastatin side effects: mood swings, pain in extremity, erectile dysfunction, insomnia.

Abdominal Distension
on Mar 01, 2014 Male from GB , 67 years of age, weighting 207.0 lb, was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: abdominal distension. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:

Myalgia, Nasopharyngitis, Headache, Constipation, Dyspepsia, Dizziness
on Mar 01, 2014 Male from GB , 75 years of age, weighting 224.0 lb, was diagnosed with and was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: myalgia, nasopharyngitis, headache, constipation, dyspepsia, dizziness. Simvastatin dosage: N/A.
Associated medications used: Patient was hospitalized.

Knee Operation
Patient was taking Simvastatin. Patient felt the following Simvastatin side effects: knee operation on Feb 28, 2014 from BR Additional patient health information: Female , weighting 143.3 lb, was diagnosed with and. Simvastatin dosage: 50 Mg, Bid.
Multiple prescriptions taken: Patient was hospitalized.

Road Traffic Accident, Dizziness, Panic Reaction, Blood Count Abnormal, Anxiety
Adverse event was reported on Mar 04, 2014 by a Patient taking Simvastatin (simvastatin) (Dosage: N/A) was diagnosed with and. Location: DE , 67 years of age, After Simvastatin was administered, patient encountered several Simvastatin side effects: road traffic accident, dizziness, panic reaction, blood count abnormal, anxiety.
Multiple concurrent drugs taken:

Myalgia, Muscular Weakness, Fatigue, Exercise Tolerance Decreased, Decreased Activity, Myositis, Blood Creatine Phosphokinase Increased, Muscle Atrophy
on Feb 26, 2014 Male from GB , 51 years of age, weighting 152.1 lb, was diagnosed with and was treated with Simvastatin (simvastatin). Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: myalgia, muscular weakness, fatigue, exercise tolerance decreased, decreased activity, myositis, blood creatine phosphokinase increased, muscle atrophy. Simvastatin (simvastatin) dosage: N/A.

Lethargy, Weight Decreased, Asthenia, Hepatitis, Myalgia
on Feb 28, 2014 Male from GB , 82 years of age, weighting 163.1 lb, was diagnosed with and was treated with Simvastatin. Patient felt the following Simvastatin side effects: lethargy, weight decreased, asthenia, hepatitis, myalgia. Simvastatin dosage: 40 Mg, Unk.
Multiple prescriptions taken:

Muscular Weakness, Fatigue, Muscle Atrophy, Blood Creatine Phosphokinase Increased, Myositis, Exercise Tolerance Decreased, Myalgia
Patient was taking Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: muscular weakness, fatigue, muscle atrophy, blood creatine phosphokinase increased, myositis, exercise tolerance decreased, myalgia on Feb 28, 2014 from GB Additional patient health information: Male , 51 years of age, weighting 152.1 lb, was diagnosed with and. Simvastatin dosage: N/A.

Dizziness, Panic Reaction, Road Traffic Accident, Blood Count Abnormal
Adverse event was reported on Feb 28, 2014 by a Patient taking Simvastatin (Dosage: N/A) was diagnosed with and. Location: DE , 67 years of age, Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: dizziness, panic reaction, road traffic accident, blood count abnormal.
Associated medications used:

Megacolon, Volvulus
on Feb 27, 2014 Male from GB , 70 years of age, was treated with Simvastatin. Patient felt the following Simvastatin side effects: megacolon, volvulus. Simvastatin dosage: 40mg.
Multiple prescriptions taken: Patient was hospitalized.

Hepatitis, Myalgia, Lethargy, Asthenia, Weight Decreased
on Feb 27, 2014 Male from GB , 82 years of age, weighting 163.1 lb, was diagnosed with and was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: hepatitis, myalgia, lethargy, asthenia, weight decreased. Simvastatin dosage: N/A.
Multiple concurrent drugs taken:

Myalgia, Nasopharyngitis, Headache, Constipation, Dyspepsia, Dizziness
Patient was taking Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: myalgia, nasopharyngitis, headache, constipation, dyspepsia, dizziness on Feb 27, 2014 from GB Additional patient health information: Male , 75 years of age, weighting 224.0 lb, was diagnosed with and. Simvastatin dosage: N/A.
Associated medications used: Patient was hospitalized.

Myopathy, Restlessness, Hot Flush, Skin Warm, Skin Burning Sensation
Adverse event was reported on Feb 20, 2014 by a Male taking Simvastatin (Dosage: (40 Mg, 1 D),oral) was diagnosed with and. Location: DE , weighting 242.5 lb, Patient felt the following Simvastatin side effects: myopathy, restlessness, hot flush, skin warm, skin burning sensation.
Multiple prescriptions taken:
  • Ezetrol ((10 Mg, 1 D),oral)
  • Sortis (atorvastatin Calcium) ((20 Mg, 1 D),oral)
  • Niaspan ((375 Mg, 1 D),oral)
Patient was hospitalized.

Abdominal Distension
on Feb 27, 2014 Male from GB , 67 years of age, weighting 207.0 lb, was treated with Simvastatin. After Simvastatin was administered, patient encountered several Simvastatin side effects: abdominal distension. Simvastatin dosage: Unk.
Multiple concurrent drugs taken:

Injection Site Erythema
on Feb 26, 2014 Female from US , 90 years of age, weighting 123.5 lb, was treated with Simvastatin. Directly after, patient experienced the unwanted or unexpected Simvastatin side effects: injection site erythema. Simvastatin dosage: N/A.
Associated medications used:

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Tips for Taking Medicines Properly

Before Taking Simvastatin

Find Out How to Take Simvastatin

Discuss Simvastatin Side Effects

Did You Have a Simvastatin Side Effect?

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How Effective is Simvastatin for You?

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JustAnswer.com

Safety Alerts, Active Ingredients, Usage Information

Alternative SIMVASTATIN Names:SIMVASTAT

Active Ingredient: SIMVASTAT

Simvastatin Dosage, Warnings, Usage.

Side Effects reported to FDA: 8348

Simvastatin safety alerts: 2011 2010 2008

Reported deaths: 559

Reported hospitalizations: 3020

Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor


 

[UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.

 

[Posted 06/08/2011]

AUDIENCE: Family Practice, Cardiology, Pharmacy

ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.

BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).

RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.  


Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[12/15/2011 - Drug Safety Communication - FDA
[06/08/2011 - Drug Safety Communication - FDA]
[06/08/2011 - News Release - FDA]
[06/08/2011 - Consumer Update - FDA

Previous MedWatch Alert

[03/19/2010]

Latest Simvastatin clinical trials